🇧🇴 ValiPro: AGEMED, WHO GMP & CTD Validation Services for Bolivia
Secure Sanitary Registration in Bolivia by Meeting AGEMED's Technical Documentation Requirements and Ensuring Compliance with WHO GMP Standards.
ValiPro provides expert Process Validation Protocol and Report services specifically designed for manufacturers targeting the Bolivian market. Our documentation is built for full compliance with the rigorous standards enforced by AGEMED.
Key compliance pillars include:
Mandatory adherence to Good Manufacturing Practice (GMP), which primarily follows WHO guidelines.
The registration dossier must be submitted in the Common Technical Document (CTD) format.
Mandatory submission of samples for quality verification by the National Laboratory.
🌟 Why AGEMED Validation is Crucial
AGEMED's process involves a two-phase evaluation: Phase I for safety and efficacy, and Phase II for Quality (CMC), GMP, and samples. Robust validation documentation is essential for success in Phase II and for subsequent quality control verification.
CTD Submission Format: AGEMED accepts the internationally recognized CTD format. Your process validation data (protocols and reports) are a critical part of the Quality Dossier (CMC Documents), which is evaluated in Phase II. The documentation must align with the structure of CTD Module 3, specifically demonstrating manufacturing process control.
GMP Acceptance: AGEMED requires a GMP Certificate for the drug product manufacturing site. AGEMED generally accepts documents issued by the authority of the country where the manufacturing site is located (WHO-GMP, USFDA, EU-GMP are valid), but may request additional information, the inspection report, or conduct its own inspection if deemed necessary. Validation reports are the scientific proof of GMP compliance.
Mandatory Laboratory Testing (INLASA): For experts to confirm the composition of the product, three product samples must be sent to the National Institute of Health Laboratories (Instituto Nacional de Laboratorios de Salud, INLASA). This makes the submission of a detailed Certificate of Analysis (CoA) and robust, validated analytical methods (AMV) critical to ensure INLASA can successfully verify the product quality.
Process Validation Expectation (Three Batches): While the specific regulation may vary, international standards referenced by AGEMED, such as those from the Andean Community, often require process validation data from a minimum of three consecutive, successfully validated production batches to prove consistency and reproducibility.
Climatic Zone IV Stability: Bolivia, following WHO guidelines for tropical countries, requires stability studies to be conducted under Climatic Zone IV conditions: $30^{\circ}C \pm 2^{\circ}C$ and $75\% \pm 5\% RH$. Your process validation must ensure that the manufacturing process is controlled to yield a product that meets these stability requirements.
🎯 Compliance Focus: Who We Support
We work with international manufacturers targeting the Bolivian market:
Pharmaceutical Exporters: Targeting Sanitary Registration for new and existing human and veterinary drugs.
CTD Documentation: Companies needing to compile their quality data into the required CTD format, specifically focusing on Module 3 (Quality).
INLASA Readiness: Firms needing robust Analytical Method Validation (AMV) reports and finished product specifications that can be readily audited and used by INLASA for mandatory testing.
🛠️ Our Process Validation Services for Bolivia
We provide complete, scientifically sound, and document-intensive support tailored to the content requirements of the AGEMED Phase II submission.
ServiceBolivia / AGEMED / CTD FocusPVP & PVR PreparationProtocols and reports aligned with WHO/ICH GMP principles, documenting manufacturing and cleaning processes, including data from three consecutive batches.CTD Module 3 IntegrationStructuring validation summaries and data precisely for the CTD Module 3 Quality section (3.2.P.3.5, 3.2.P.5).Analytical Validation SupportPreparation of detailed AMV reports to accompany the required Certificate of Analysis and facilitate INLASA's testing and verification.Climatic Zone IV Stability ReviewEnsuring stability data meets the required long-term conditions of $30^{\circ}C/75\% RH$ and is adequately summarized for the dossier.Spanish Translation SupportAssistance in the accurate translation of technical validation summaries and key quality documents into Spanish for submission.
📜 Regulatory Standards We Follow
Our documentation is engineered to align with the core standards adopted and enforced by AGEMED:
Law 1737 and Supreme Decree 25235: The national legal framework.
WHO GMP Guidelines: The underlying international benchmark for manufacturing practice compliance.
CTD Format: The required structure for the registration dossier.
🤝 Get Started on Your Bolivia Validation
Ensure your process validation documentation is robust, correctly formatted, and immediately acceptable to AGEMED, securing your necessary approvals and market access in Bolivia.
To receive a Technical Scope and Commercial Proposal tailored for your Bolivian project, simply provide:
Product: Dosage form (e.g., solid oral, injectable, API) and Batch Size
Target Status: New Registration (Phase II submission) / Renewal
Manufacturing Process: Overview of critical steps and control strategy
Timeline: Submission date
Existing Data: Any current validation documents or AGEMED deficiency letters.